The present invention relates to a catheter securement system for the prevention of the accidental removal or malpositioning a variety of catheter styles. More specifically, the present invention relates to a two-piece catheter securement device having a shell-like capture and retention cover releasably engagable with a lower fixation pad adhesively attachable to the body of a patient.
It is known in the art relating to catheters that after insertion of a catheter through a patient's skin into a vein, the catheter must be secured to prevent the catheter from slipping out of the patient's vein. Commonly, surgical tape is used to hold the catheter hub or tubing connected to the catheter to the patient's skin. Oftentimes, this method is ineffective to permanently, securely anchor the catheter and to prevent catheter movement.
Further, inadvertent movement of a catheter while the catheter is inserted in a vein is a leading cause of premature catheter failure. When a catheter moves in a vein, it scrapes and pokes the inner wall of the vein, thereby irritating the vein. Repeated movement of the catheter thereby causes sufficient irritation of the vein to require the catheter to be removed and a new catheter inserted in a different location along the same vein or in an entirely new vein. This is costly as it results in a waste of resources. Also, repeated movement of an inserted catheter can cause migration of the catheter in the vein or worse, may lead to the catheter being removed from the vein. Therefore, a need exists for effective anchoring/securement devices for catheters.
Moreover, it is also known to use a catheter dressing with pressure sensitive adhesives to fully secure and protect a catheter such as a Peripherally Inserted Central Catheter (“PICC”). PICCs are typically made of polyurethane or silicone based materials. Due to the low surface energy of silicones, adhesives from dressings do not fully anchor or grip to silicone substrates as well as polyurethane materials. Thus, PICC movement will occur when a PICC covered with a dressing is tugged or pulled.
While there are numerous prior art securement devices, as described below, most recent prior art devices utilize a complex mechanical arrangement of parts which secure a catheter by engaging and securing the catheter hub and hub wings. The prior art devices generally are integral units which include a cover attached or hinged to a base, but not separable.
The present invention offers a unique solution to the problem of immobilizing the catheter assembly. It may be applied to various catheters or conduits exiting or entering the patient's body including, but not limited to, central line catheters, peripheral intravenous (IV) catheters, urinary drainage catheters including the Foley catheter, gastric feeding tubes, chest tubes, Huber needles utilizing subcutaneous ports, and other catheters or tubing that require immobilization.
Certain terminology is used in this disclosure for convenience only and is not to be taken as a limitation on the present invention. The terms “distal” and “proximal” refer, respectively, to directions closer to and away from the insertion tip of a catheter in an implantable catheter assembly. The terminology includes the words specifically mentioned, derivatives thereof and words of similar import.
U.S. Pat. No. 8,137,326 discloses a hub for a triple lumen catheter assembly of the type commonly used in the field of medical devices and, more particularly, to catheters and catheter assemblies. Such hubs accommodate a multiplicity of extension tubes, commonly referred to as administration tubes, at a proximal side of the hub and at least one catheter tube on a distal side of the hub extending to a distal tip inserted into the patient's body.
The prior art hub has a body portion with a distal end and a proximal end and a central region from which laterally, outwardly extend a pair of suture wings with suture openings therethrough to facilitate anchoring the hub to the patient after the catheter implantation procedure is complete. In many medical procedures the hub is not sutured to the patient even though the hub has wings and suture openings. Nothing in U.S. Pat. No. 8,137,326 teaches or discloses a catheter securement device.
A catheter securement device to secure silicone winged peripherally inserted central catheters (PICCs) is disclosed in U.S. Pat. Pub. No. US2012/0109070A1. This securement device is designed to be used to anchor catheters having wings. The device includes a fabric, sheet-like, anchoring member having a top surface, an opposite bottom surface, a base portion, and a pair of strap portions extending from the base portion. The anchoring member includes an adhesive on the bottom surface in the base portion and is generally adhesive free on the top surface in the base portion.
The anchoring member also includes an adhesive on the top surface in the strap portions and is generally adhesive free on the bottom surface in the strap portions. The base portion is mountable on a patient's skin intermediate a catheter hub having wings, and each strap portion is foldable over the base portion and one catheter hub wing to secure the catheter hub.
Further, features of the strap portions include leg and foot members, perforation lines, fold lines which require precise folding and placement to secure the catheter hub. The hub is basically wrapped and secured by the fabric sheet and stuck to the patient; the device, while seemingly simple in parts, is very complex to utilize.
U.S. Pat. No. 8,197,447 teaches a venipuncture site protector which includes a securement and a cover mounted to the securement. The cover includes a proximal end having a front wall with a tube receiving slot. The cover also includes a distal end having an arch that forms an opening that lies on a vertical plane that is substantially perpendicular to the securement. The cover is permanently mounted on the securement once the cover is attached to the securement.
Another prior art universal catheter securement device is disclosed in U.S. Pat. No. 8,016,792, as having a complex arrangement of a cover or shell member attachable to a base which when engaged restrains longitudinal movement of catheter hub wings between front and rear locating elements. With smaller or narrower catheters, a gap is left between the wings and the locating elements which would normally allow the catheter to shift longitudinally under force (e.g. with pulling on the catheter tubes). However when the cover is closed, the catheter body and/or wings are clamped tightly by the capture elements. Thus, in the device of U.S. Pat. No. 8,016,792, an inner cover or shell surface engages with the catheter hub and/or wings.
U.S. Pat. No. 7,922,697 discloses yet another catheter securement device having an adhesive backed base pad with a fixed plate and a rotatable adjustable plate permanently affixed to the base pad. Posts are on the fixed plate and the adjustable plate to secure a winged catheter. There is no cover or shell cooperatively engaging the base to secure tubing to and from a catheter hub.
U.S. Pat. Nos. 6,770,055 and 6,582,403 both relate to universal catheter anchoring systems having a cover section hingedly attached to a base member of a retainer permanently affixed to an anchor pad with adhesive disposed on a lower or under side of the anchor pad. The system includes at least one post movably attached to either the base or the cover and arranged so as to lie at least partially between the cover and the base when the cover is in a closed position.